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Drug Facts
For occasional use only. Not intended as a substitute for sleep.
Stay Awake Tablet
FDA Label NDC 72036-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Stay Awake (NDC 72036-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, use, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Caffeine 200 mg
Purpose
Alertness aid
Use
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Otc - Do Not Use
Do not use in children under 12 years of age
Otc - When Using
When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Otc - Stop Use
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours
Other Information
- each tablet contains: calcium 80 mg
- store at room temperature 15°-30°C (59°-86°F)
- retain carton for complete product information
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dibasic calcium phosphate, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, pregelatinized starch
Principal Display Panel
Harris Teeter
Stay Awake
Compare to the Active Ingredient in Vivarin(R)
Caffeine, 200 mg
ALERTNESS AID
Safe and Effective
40 Tablets
Image Description (F102002hte R0)
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